1. Reservation of Copyright
The disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the U.S. Patent and Trademark Office patent files or records, but otherwise reserves all copyrights whatsoever.
2. Field of Invention
This invention relates to a system, method and apparatus for maintaining a cord stem cell registry. More particularly, this invention relates to a method and system for a mixed-use bank of placental and umbilical cord stem cells.
3. Description of Background Information
Placental and umbilical cord stem cells (hereinafter "cord stem cells"), harvested from the placenta and umbilical cord of newborn infants, has been found to contain a high concentration of hematopoietic stem cells which create the blood and immune systems. These stem cells have been successfully used in transplant settings for a wide variety of diseases including certain cancers such as leukemia, blood anemias and genetic disorders.
Medical applications of cord stem cells are becoming well-known in and out of the medical community. For general discussions as well as particular applications of cord stem cells, see, for example, J. Stephenson, "Terms of Engraftment: Umbilical Cord Blood Transplants Arouse Enthusiasm," 273 JAMA 23, Jun. 21, 1995; John E. Wagner et al, "Allogeneic sibling umbilical-cord-blood transplantation in children with malignant and non-malignant disease," 346 The Lancet 8969, pp. 214-219, Jul. 1995; and Clare Thompson, "Umbilical Cords: Turning Garbage Into Clinical Gold," 268 Science 805, May 12, 1995.
As a result of the successful clinical experiences and the large number of people who have benefitted from the medical uses of cord stem cells to date (or who will benefit from cord stem cells uses in the future), several cord stem cell banks have been established.
To date there are two kinds of cord stem cell banks. The first kind of cord stem cell banks, family banks, store harvested cord stem cells for a donor's family and provide a sample of the donated cord stem cells back to the donor family if needed. Public banks have been established to provide typed, anonymous samples to the general public based on genetic matching with needy potential recipients. A general discussion of various ethical issues relating to cord-blood banks is provided in Jeremy Sugarman et al, "Ethical Aspects of Banking Placental Blood for Transplantation," 274 JAMA 22, pp. 1783-85, Dec., 13, 1995.
While there are ethical advantages, possibly even requirements, on anonymity of cord stem cell samples, there are some definite disadvantages. First, there is always the possibility that the donor family will need to use the sample, and anonymity makes such a use more difficult. Further, even if a cord stem cell sample is used by an individual not related to the donor family, there may still be advantages in being able to find out more information about the donor and/or the donor's family. For example, the ability to find out information about the donor (obtain a "then current look" in the future at the time of use to the donor) can reduce the risk of transmitting acquired or genetic diseases on transplant of the cord stem cells years later.
The so-called public cord stem cell banks generally allow for an initial non-anonymous period of cord stem cell sample storage, say, six months, after which the samples are anonymized in order to prevent future ethical conflicts. Once a sample is anonymized, it is not possible for a user of a public cord stem cell bank to look back to the donor or the donor's family.
No mixed-use cord stem cell banks have yet been established. That is, no cord stem cell banks have been established which allow for both typed, anonymous samples and for exclusive family use and retention of the cord stem cell samples.